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As a Scientist 1 within Clearance Services you will be responsible for providing scientific support in the conduct of routine GLP or GMP studies performed within a contract testing laboratory. You will be acting as Study Director or Responsible Scientist for routine GLP or GMP studies respectively, assisting in the performance of laboratory procedures, providing scientific support to laboratory staff performing routine procedures and external clients for whom the studies are being performed. You will be required to maintain study records, including deviation records, to meet regulatory standards.
Who you are:
- Work within the laboratory areas providing hands-on support, training, guidance and mentorship to laboratory based personnel to ensure routine client studies are completed on time to the appropriate scientific and regulatory standards
- Respond to audit observations through the Integrated Quality System (BRIQS)
- Raise and progress deviation and Corrective or Preventative Action (CAPA) records in a timely manner
- Write and review regulatory documents including Standard Operating Procedures (SOPs), protocols, technical specifications and reports for routine procedures and assays
- Liaise with Commercial, Development Services, Programme Management and other Laboratory Operations to provide technical support for ongoing and upcoming projects, as required
- Participate in external and internal client conference calls, meetings and audits, including regulatory audits
- Proactively implement improvements to laboratory processes and procedures to improve efficiencies and reduce waste
- Responsible for ensuring all consumables and reagents relative to their studies are available in advance of study initiation
- Perform regular housekeeping and Health and Safety audits
- Ensure trending spreadsheets are completed in a timely manner for all studies in accordance with relevant SOP
- Write and review assay risk assessments related to area of operational expertise
- Write Genetically Modified Organism (GMO) risk assessments
- Actively maintains a clean, tidy and safe work environment
- HND or higher qualification in a relevant scientific subject
- Minimum of 5 year experience of working within a scientific laboratory, ideally within a regulated environment.
- The successful candidate will be able to work in a fast pace, volume based environment with excellent communication skills both written and verbal
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
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